脳卒中後の無気力に対する促進された rTMS

実験的：反復経頭蓋磁気刺激

すべての参加者は、内側前頭前皮質 (mPFC) での加速された高用量反復経頭蓋磁気刺激 (rTMS) を 600 パルスの実行で 1 日 12 回、7 週間以内の 3 日間 (連続または非連続) 受けます。 -日の期間。

デバイス：MagVenture MagPro 経頭蓋磁気刺激 (TMS) システム

治療は、7 日間の期間内の 3 回の治療日ごとに、約 3 分間のセッションを 12 回行います。 参加者のアドヒアランスと定着を促進するために、治療日が連続している必要はありません。 1 つのセッションは、120% の安静時運動閾値 (rMT) の強度で dmPFC に送達される 600 パルスで構成されます。 50 Hz の三相バーストが 2 秒間配信され、その後 8 秒間のトレイン間インターバルが続きます。 トレインは 10 秒ごとに合計 10 回繰り返され、セッションあたり合計 190 秒になります。 12 の各セッションの間には、少なくとも 15 分のセッション間隔が設けられます。 したがって、各治療日の持続時間は約 3 ～ 4 時間となります。

他の名前：

• Brainsight ニュ​​ーロナビゲーション システム

Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline

The Lille Apathy Rating Scale (LARS) is a validated 33-item structured interview assessing apathy across 9 domains, including intellectual curiosity, emotion, action initiation, self-awareness, productivity, interests, novelty seeking, motivation, and social engagement.

Total scores range from -36 to +36, with higher scores indicating greater severity of apathy (worse outcome) and lower (more negative) scores indicating less apathy (better outcome).

The total score is calculated by summing responses across all items and domains to generate a composite score.

Treatment-Emergent Adverse Events and Side Effects as Assessed by Intermittent Theta Burst Stimulation Review of Systems (iTBS ROS)

A review of systems questionnaire (Intermittent Theta Burst Stimulation Review of Systems; iTBS ROS) was administered repeatedly during each treatment day to assess treatment-emergent symptoms.

Symptoms were rated on a scale from 0 to 5 (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, 5 = severe), with higher scores indicating greater symptom severity (worse outcome).

Values reported represent the average symptom severity across all assessments collected during the 3 treatment days for each participant, and then averaged across participants.

Change in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) Compared to Baseline

The Montreal Cognitive Assessment (MoCA) is a clinical assessment of cognitive function. The MoCA assesses multiple cognitive domains including memory, visuospatial skills, executive function, attention, concentration, calculation, language, abstraction, and orientation. The MoCA can be administered in approximately 10 minutes and total scores range from 0 to 30 with lower scores correlating with greater degree of cognitive impairment.

Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery Compared to Baseline

Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 5 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, dimensional change card sort tests, and picture sequence memory. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. There are no established thresholds or cutoffs for clinically distinct or diagnostic categories.

Participant Retention Rate

Percentage of participants who completed the study relative to all participants who initiated treatment

Change in Apathy Symptoms, as Measured by the Apathy Evaluation Scale (AES) Compared to Baseline

The Apathy Evaluation Scale (AES) clinically validated rating scale assessing symptoms of apathy. The AES is comprised of 18 items rated on a four-point Likert-Scale assessing and quantifying emotional, behavioral and cognitive aspects of apathy. Total scores on the AES range from 18 to 72 with high scores correlating with greater severity of apathy.

Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form

The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form is a validated patient-reported outcome measure assessing depressive symptoms, including negative mood, cognitive symptoms, and decreased positive affect.

Scores are reported as T-scores standardized to the U.S. general population, where a T-score of 50 represents the population mean and 10 represents the standard deviation.

Higher T-scores indicate greater depressive symptom severity (worse outcome), while lower T-scores indicate fewer depressive symptoms (better outcome).

T-scores of approximately 60 or greater are generally considered indicative of at least mild clinically elevated depressive symptoms, with higher thresholds reflecting increasing severity.